Dietary intakes

Mean dietary intakes of aflatoxins for various regions were estimated using regional diets from the Global Environment Monitoring System - Food Contamination Monitoring and Assessment Programme combined with data on levels of aflatoxin contamination. The Committee considered the possible impact of applying two hypothetical standards to aflatoxin contamination - 10 and 20 mg per kilogram. These should not be construed as recommended standards; they were chosen for illustrative purposes only. Governments and CAC should perform this type of analysis for particular standards that are being considered, basing it on their own data on contamination, dietary patterns and prevalence of hepatitis B. Two examples using these hypothetical standards were developed. In the first example, it was assumed that the level of contamination of food by aflatoxins is low and the proportion of the population that is hepatitis B surface antigen positive is small. Monitoring data from Europe on aflatoxin B1 levels in groundnuts, maize and their products were used and it was assumed that 1 percent of the population is hepatitis B surface antigen positive. Assuming that these foods are ingested according to the "European diet", the mean estimated intakes of aflatoxins are 19 ng per person per day when a standard of 20 mg per kilogram is applied and 18 ng per person per day with a standard of 10 mg per kilogram. Using the potency estimates shown in the Figure, these intakes translate into estimated population risks of 0.0041 and 0.0039 cancers per year per 100 000 people when standards of 20 and 10 mg per kilogram, respectively, are applied. Thus, reducing the hypothetical standard from 20 mg to 10 mg per kilogram yields a reduction in the estimated population risk of approximately two cancers per year per 1 000 million people. The second example pertains to areas with higher levels of aflatoxin contamination and a larger percentage of the population carrying the hepatitis B virus. Monitoring data from China on aflatoxin B1 levels in groundnuts, maize and their products were used, and it was assumed that 25 percent of the population is hepatitis B surface antigen positive. Assuming that these foods are ingested according to the "Far Eastern diet", the mean estimated intakes of aflatoxins are 125 ng per person per day when a standard of 20 mg per kilogram is applied and 103 ng per person per day with a standard of 10 mg per kilogram. Using the potency estimates in the Figure, these intakes translate into estimated population risks of 0.17 and 0.14 cancers per year per 100 000 people when standards of 20 mg and 10 mg per kilogram, respectively, are applied. Thus, reducing the hypothetical standard for this population from 20 mg to 10 mg per kilogram yields a reduction in the estimated population risk of approximately 300 cancers per year per 1 000 million people. These calculations, and the basis for them, are explained in more detail in WHO, 1998 and WHO, 1999. The differences in population risks between these hypothetical standards are lower than might be expected on a first analysis. However, the results are not surprising when it is considered that, in both cases, the most highly contaminated samples are eliminated, thus greatly reducing average estimated intakes of aflatoxins. The use of standards by all countries should, therefore, be encouraged.

CONCLUSIONS

After reviewing and analysing the data, the Committee came to the following conclusions:

Aflatoxins are considered to be human liver carcinogens, aflatoxin B1 being the most potent. Aflatoxin M1 has a potency approximately one order of magnitude lower than that of B1. The potency of aflatoxins in individuals who carry hepatitis B is substantially higher than in those who do not carry it. Thus, reduction of the intake of aflatoxins in populations with a high prevalence of hepatitis B will result in a greater reduction in liver cancer rates than reduction of the intake of aflatoxins in populations with a low prevalence of hepatitis B. Vaccination against hepatitis B will reduce the number of carriers of the virus. The present analysis suggests that reducing the number of carriers would reduce the potency of aflatoxins in vaccinated populations and, consequently, reduce the risk of liver cancer. Analyses of the application of hypothetical standards for aflatoxin contamination in food (10 mg or 20 mg per kilogram) to model populations indicate that: populations in which the prevalence of hepatitis B surface antigen positive individuals is low and/or in which the mean intake of aflatoxins is low (less than 1 ng per kilogram of body weight per day) are unlikely to exhibit detectable differences in population risks; populations in which both the prevalence of hepatitis B surface antigen positive individuals and the intake of aflatoxins are high would benefit from reductions in aflatoxin intake. Reductions in the intake of aflatoxins can be achieved through avoidance measures such as improved farming and proper storage practices and/or through enforcing standards for levels of contamination in food or feed within countries and across borders. When two alternative standards for aflatoxin contamination in food are considered, the higher standard will yield essentially the same risk as the lower standard if the fractions of samples excluded under the two standards are similar. When a substantial fraction of the current food supply is heavily contaminated with aflatoxins, reducing the levels of contamination may result in a detectable reduction in rates of liver cancer. Conversely, when only a small fraction of the current food supply is heavily contaminated, reducing the standard by an apparently substantial amount may have little appreciable effect on health.

FAO and WHO encourage governments and CAC to make use of this evaluation in deciding on the appropriate standards to apply to aflatoxins. Significant resources are required, however, as use of the evaluation requires a significant amount of information at the national level, including monitoring data and information on dietary patterns and the prevalence of hepatitis B in the population. A comforting factor is that risks are significantly reduced when the most highly contaminated samples are eliminated. This can be done without a detailed analysis of the risk, and governments are encouraged at least to take this step if they are lacking the information necessary to make full use of the evaluation carried out by JECFA

PRE-HARVEST CONTROL
Prevention through pre-harvest control is the first step in ensuring a safe final product. While an association between mycotoxin contamination and inadequate storage conditions has long been recognized, studies have revealed that some seeds are contaminated with mycotoxins in the field. During the growing period, the seeds are exposed to environmental factors, such as weather, that are impossible to control. Once the crop becomes infected under field conditions, fungal growth will continue during post-harvest stages and storage. Thus, pre-harvest management is focused on controlling critical factors that have been shown to enhance mycotoxin production. Some of the most common strategies used for pre-harvest management are:

Management of insect infestation. Although it has been reported that damage is not a prerequisite for aflatoxin formation, the incidence of Aspergillus flavus and A. parasiticus is usually higher in damaged kernels. Insect-damaged kernels are routes for infection and are likely to dry to moisture levels that are more favourable for the growth of A. flavus and aflatoxin production than of other fungi. Control of insect infestation may, therefore, help to prevent A. flavus and A. parasiticus proliferation and subsequent aflatoxin production. Management of crop residues and crop rotation. Inoculum potential is a prerequisite for Aspergillus infection and subsequent aflatoxin production. Soil type and condition, as well as availability of viable spores, have been considered important factors in aflatoxin production. When the crop is harvested, some residues remain on the field. These provide an environment that is conducive to the survival of fungal spores and the subsequent infection of the next crop. Proper management of crop residues would help avoid this problem. Crop rotation has also been recognized as an important factor in the spread of the inoculum. Adequate rotation may, therefore, aid the prevention of mycotoxin contamination. For example, field trials have reported that a maize-soybean rotation yielded a less extensive outbreak of Fusarium than did maize-maize planting operations. Irrigation and soil condition. Soil fertility and drought stress have been found to be contributing factors in pre-harvest aflatoxin contamination of maize. Moisture and temperature play the most important roles in the planning of any control strategy for fungal development. High moisture and high relative humidity are essential for spore germination and fungal proliferation. Therefore, adequate efforts should be made to avoid extreme conditions of either drought or excessive moisture. Some studies have shown that drought stress followed by high-moisture conditions is ideal for Fusarium moniliforme proliferation and fumonisin production. When this type of weather condition is present, it can be assumed that some degree of mycotoxin contamination will occur and other prevention/management strategies should be explored.

Development of resistant plant varieties

There has been extensive research on the development and promotion of plant varieties that are naturally resistant to fungal infection. Host resistance may present a promising strategy for the

pre-harvest prevention of mycotoxin contamination. Until recently, the search for naturally resistant maize genotypes had not been successful. However, during extensive field testing, maize breeding populations with aflatoxin resistance have been identified. Genetic studies of these specific populations have yielded useful information for the development of resistant lines. Studies have identified the chromosome regions associated with aflatoxin resistance. This line of research is, therefore, a good option for future pre-harvest control and prevention of mycotoxin formation. Genetic engineering has also been useful in the development of host resistance through the addition or enhancement of antifungal genes. Many endogenous compounds with low molecular weight and biomacromolecules in kernel tissues have been identified as antifungal compounds. Enhancing the production of these compounds may also enhance resistance to mycotoxin contamination. There may be toxicity implications associated with these antifungal compounds.

HARVEST CONTROL
During harvesting, it is important to control factors such as timeliness, clean-up and drying of the agricultural product. Such control is essential for preventing mycotoxin formation during storage. Studies have shown that the timing of harvesting greatly influences mycotoxin production. In some geographical regions, the planting date should be selected to take advantage of periods of higher rainfall. Harvesting should take place as soon as the crop is fully grown and the crop cycle is completed. Studies have reported that crops left on the field for longer periods of time may present higher levels of toxin contamination. Adequate drying is also essential to prevent fungal proliferation during storage.

POST-HARVEST CONTROL AND DECONTAMINATION

Although prevention is the best control strategy, mycotoxin contamination will still sometimes occur. Post-harvest control and decontamination procedures represent, therefore, an important tool in avoiding consumer exposure. Several decontamination strategies have been reported for various mycotoxins, and specific information on each method is readily available in the literature. Some traditional processing methods are good either for physically separating toxins or for chemically inactivating them. However, the effectiveness of each processing method should be evaluated for the specific commodity and toxin present in the system.

BOX 2 CRITERIA FOR EVALUATING MYCOTOXIN REDUCTION OR DECONTAMINATION PROCEDURES

Procedures for the evaluation and acceptance of given mycotoxin reduction or decontamination should (Jemmali, 1979; Park et al., 1988; Jemmali, 1989):

- inactivate, destroy or remove the toxin; - not produce or leave toxic residues in the food or feed; - retain nutritive value and food/feed acceptability of the product; - not alter significantly the technological properties of the product; - destroy fungal spores, if possible.

COMMON POST-HARVEST STRATEGIES

Physical methods of mycotoxin removal
Once a contaminated product has reached a processing facility, clean-up and segregation are the first control options. These procedures are usually non-invasive and, except for milling, will not alter the product significantly. In some cases, these are the best methods of reducing mycotoxin presence in final products. For example, when peanuts are processed, a significant amount of aflatoxins can be removed by electronic sorting and hand-picking (Table 1) (Dickens and Whitaker, 1975; Kirksey, Cole and Dorner, 1989). Separation of mould-damaged maize (Figure 4) and/or screening can significantly reduce fumonisin and aflatoxin concentrations (Bennett, Rottinghaus and Nelson, 1992; Murphy, Rice and Ross, 1993). In addition, the removal of rot from apples significantly reduces the patulin content in the final product (Lovett, Thompson and Boutin,1975). Although some contamination may persist, physical removal represents a good alternative for industry (Lopez-Garcia, Park and Gutierrez de Zubiarre, 1999; Lopez-Garcia and Park, 1998).

TABLE 1 Effectiveness of post-harvest aflatoxin management strategies at the processing level1

Technology Farmer's stock Belt separator Shelling plant Gravity table2 Blanching/colour sorting Colour re-sorting2
1 2 2 2

Aflatoxin level (g/kg) 217.0 140.0 100.0 30.0 25.0 2.2 1.6

Reduction (%) 35 29 70 16 91 27

Cumulative reduction 35.0 54.0 86.0 88.0 99.0 99.3

Colour sorting

Results from the processing of a 40 000 kg segregation I lot of contaminated peanuts. Data based on medium-category peanuts only. Source: Park and Liang, 1993.

Henry Njapau/National Council for Scientific Research, Zambia 4. Mould-damaged maize in a ship's hold (typical hot spot); process of physical separation of damaged from intact kernels

Milling is traditionally used for grain processing. This method will separate the grain into different fractions (Bennett and Anderson, 1978; Bennett et al., 1976; Bennett and Richard, 1996; Bennett et al., 1978; Seitz et al., 1986; Schroeder, Boller and Hein, 1968). It is, therefore, important to identify the fractions that remain toxic so that they can be diverted to lower-risk uses or subjected to decontamination procedures (Scott, 1984; Wood, 1982).

Physical methods of decontamination

Some phases of industrial processes can reduce specific mycotoxins to a certain degree through thermal inactivation, but some mycotoxins are chemically stable and will not be completely destroyed at processing temperatures. Thus, thermal inactivation for a particular toxin should be evaluated for the temperatures of a specific process. Roasting is a good method for such commodities as peanuts and coffee. As mentioned before, if a traditional processing method is an effective decontamination procedure, it should be the first choice for management of a particular product (Lopez-Garcia and Park, 1998).

Irradiation may also be an option for mycotoxin control. A completely satisfactory way of destroying mycotoxins that have already been formed has not been identified. However, irradiation may be considered as a method to control mycotoxin-producing moulds in certain products (Lopez-Garcia and Park, 1998). A novel approach to the prevention of aflatoxin intoxication in some animals is the dietary inclusion of aflatoxin-selective clays that tightly bind these poisons in the gastrointestinal (GI) tract, significantly decreasing their bio-availability and associated toxicities (Phillips, Clement and Park, 1994). These methods aim at preventing the deleterious effects of mycotoxins by sequestrating them to various sorbent materials in the GI tract, thereby altering their uptake and disposition to the blood and target organs. In pioneering studies, a phyllosilicate clay which was commonly used to reduce caking in animal feeds (NovaSil or hydrated sodium calcium aluminosilicate [HSCAS] clay) was reported to adsorb aflatoxin B1 with high affinity and high capacity in aqueous solutions (including milk); reduce markedly the bio-availability of radiolabelled aflatoxins in poultry; diminish significantly the effects of aflatoxins in young animals such as rats, chicks, turkey poults, lambs and pigs; and decrease the level of aflatoxin M1 in milk from lactating dairy cattle and goats. The effects of HSCAS clay in the diet did not alter the hyperoestrogenic effects of zearalenone (Grant, 1998; Grant and Phillips, 1998; Machen et al., 1988; Lemeke, Grant and Phillips, 1998; Ramos and Hernandez, 1996). A variety of other HSCAS binding agents are purported to adsorb aflatoxins, as well as other chemically diverse mycotoxins such as T-2 toxin, ochratoxin, deoxynivalenol, zearalenone and fumonisins. It is, therefore, possible that these agents may be non-selective in their action and pose significant hidden risks arising from their interaction with critical nutrients, etc. In addition, in vitro (test-tube) evidence indicated that some of these binders may provide little (if any) protection from aflatoxins or other mycotoxins. Granulated activated carbon (GAC) has also been studied for its ability to bind aflatoxins, both in vivo and in vitro. Results from studies using GAC varied widely according to the type of activated carbon used. Activated carbon has also proved effective in reducing patulin in naturally contaminated fruit juices (Sands, McIntyre and Walton, 1976; Walton, Sands and McIntyre, 1976; Decker, 1980). Clay and zeolitic minerals comprise a broad family of functionally diverse silicoaluminosilicates. Although, these agents have shown promising effects on the binding of mycotoxins, there may be significant risks associated with the inclusion of non-selective clays (or other adsorbents) in the diet. Aflatoxin adsorbents should be rigorously tested, with particular attention to their effectiveness and safety in aflatoxin-sensitive animals and their potential for interaction with nutrients.

Biological decontamination
Biological methods have been explored as options for mycotoxin decontamination. In the fermenting industry it has been found that aflatoxins are not degraded during fermentation; although the toxins are absent from the alcohol fraction after distillation. Aflatoxins are usually concentrated in the spent grains. When contaminated products are used for fermentation, it is

therefore important to determine the end use of the contaminated by-products. It should be emphasized that biological methods demonstrating effective decontaminating properties usually depend on specific compounds produced by selected microorganisms. When a specific compound is found to be a good decontaminating agent, it is usually more efficient and economical to add the active agent directly. Studies suggest that certain fungi, including A. parasiticus, degrade aflatoxins, possibly through fungal peroxidases. Fermentation with yeasts has also been effective in destroying patulin and rubratoxin B (Lopez-Garcia and Park, 1998).

Chemical inactivation
Numerous studies have evaluated the use of chemicals for the inactivation and hazard reduction of selected mycotoxins. Most studies have, however, focused on aflatoxins and application to animal feeds. Ammoniation is the chemical method that has received the most research attention. Extensive evaluation of this procedure has demonstrated that it is an efficacious and safe way of decontaminating aflatoxin-contaminated feeds. More than 99 percent effective, this process has been used selectively with success in the United States, France, Senegal, the Sudan, Brazil, Mexico and South Africa, in some cases for almost 20 years. The two ammoniation processes primarily used for aflatoxin contamination in maize, peanuts, cottonseed and meals are: high pressure/high temperature(HP/HT); and atmospheric pressure/ambient temperature (AP/AT) where the HP/HT process is used for feedmill operations (Figures 5 and 6) and AP/AT is primarily for on-farm use (Figure 7). The AP/AT process is limited to dealing with aflatoxins in whole-kernel seeds/nuts. Ammoniation has been shown to be less effective against fumonisin decontamination. For aflatoxin control, however, practical applications together with research results strongly support the use of ammonia treatment. Other chemical-based procedures utilizing, for instance, monomethylamine, lime or urea/urease have been reported. In-depth reviews and articles have been published and these can be used as a basis for policy-making decisions (Lopez-Garcia, Park and Gutierrez de Zubiarre, 1999; Lopez-Garcia and Park, 1998; Park et al., 1988; Park and Stoloff, 1989; Phillips, Clement and Park, 1994; Piva et al., 1995).

R.D. Walker/Walker Cottonseed 5. Ammonia mycotoxin decontamination plant (Walker Cottonseed, Stanfield, Arizona) using the high temperature/high pressure process

R.D. Walker/Walker Cottonseed 6. Mobile ammonia mycotoxin decontamination unit capable of on-site processing using the high temperature/high pressure process

Ralph L. Price/University of Arizona, Tucson

Douglas L. Park/Louisiana State University, Baton Rouge 7. Ambient temperature/atmospheric pressure mycotoxin decontamination process showing addition of aqueous ammonia and bagging operations

Nixtamalization, the traditional alkaline treatment of maize used to manufacture tortillas in Latin America, partially degrades aflatoxins and fumonisin, but the residual molecules can either be regenerated by digestive processes or become more toxic (Price and Jorgensen, 1985). The addition of oxidizing agents, such as hydrogen peroxide, has been shown to be an effective aid in

nixtamalization. These chemicals degrade aflatoxins and fumonisin, thereby reducing toxicity (Lopez-Garcia, 1998; Burgos-Hernandez, 1998). Some recent studies have shown that hydrogen peroxide and sodium bicarbonate are effective for simultaneous degradation/detoxification of aflatoxins and fumonisin. Other chemical processes that have shown promise in controlling aflatoxins are the use of sodium chloride during thermal processing, sodium bisulphite at various temperatures and ozonation. Wet and dry milling processes, which are widely used for maize and cereal grains, have been shown to result in reduced mycotoxin levels (zearalenone, fumonisins, aflatoxins, trichothecenes and ochratoxin A) in several fractions such as milling solubles, gluten, fibre, starch and germ (Lopez-Garcia and Park, 1998). Processing alters food matrices into different complex systems. It also adds new ingredients and conditions. These new factors change the environment, and innumerable new interactions may take place. Exploring the application of known food additives to the control of mycotoxins during processing may provide new opportunities for risk management by chemical methods.

CONCLUSIONS
Mycotoxins are a chemically diverse group of fungal metabolites that have a wide variety of toxic effects. In a normal varied human diet, constant exposure to low levels of several toxins is possible. Information on the potential interactions among all these compounds is still very limited. Furthermore, some mycotoxins, such as aflatoxin B1, are known to be associated with animal and human disease. The development of practical control and management strategies is, therefore, essential to ensure consumer safety. Because of the unpredictable, heterogeneous nature of mycotoxin contamination, 100 percent destruction of all mycotoxins in all food systems is not considered a practical option. However, a practical approach would be the use of a HACCP-based "hurdle" system, in which contamination is controlled throughout production and post-production operations. An example of this is presented in Table 1 - the procedures referred to are used by the peanut industry in the United States in processing peanut butter for human consumption. Integrated mycotoxin management systems should consider control points from the field to the consumer. This type of management system considers the communication between experts in pre-harvest, harvest and post-harvest control. With this approach, every phase of production would help reduce the risk, so by the time the final food or feed reaches the consumer the hazards associated with mycotoxin contamination have been minimized. These concepts are summarized in Table 2. Continued research is required in these areas to provide more effective management of the risks posed by mycotoxin contamination. In the meantime, procedures that have proved effective for specific mycotoxins and/or commodities should be evaluated for other applications.

TABLE 2 Purpose, status and application of pre-harvest, harvest and post-harvest procedures for removing mycotoxins from human foods and animal feeds
Procedure Pre-harvest Reduction of insect infestation Aflatoxins, fumonisins Maize, cottonseed Avoid insect infestation which can serve as a vector for mould invasion to agricultural commodities; use integrated pest management control programmes Limit mould inoculum in the field Avoid drought stress during crop growth Strong potential for control of mycotoxin formation during crop growth Reduce exposure to toxigenic moulds and and moisture levels in commodities Effective in reducing mycotoxin levels in final product; mycotoxins can diffuse into apparently good commodities Mycotoxins Commodities Purpose/status/application

Crop rotation Irrigation Planting of resistant varieties

Aspergillus, Fusarium Maize, soybean toxins Aspergillus, Fusarium Maize, cottonseed, toxins peanuts, tree nuts Aflatoxins Maize

Harvesting operations Timeliness of clean-up Aflatoxins and drying of commodities Post-harvest procedures Physical separation of Aflatoxins, damaged, immature fumonisins and mould-infested kernels, nuts, seeds, etc. Thermal processing Dietary mycotoxinselective clays Maize, peanuts Maize

Aspergillus, Fusarium Maize, cereal grains, However, many mycotoxins toxins coffee are thermally stable Aflatoxins, Fusarium Maize toxins, ochratoxin A Strong potential and application for clays shown safe and effective; some non-selective clays may pose significant risk by binding critical nutrients, etc. Feed mill and farm

Chemical inactivation Aflatoxins,

Maize, peanuts,

by ammoniation

fumonisins

cottonseed and meals applications Maize Maize Strong potential; more research needed Minor modification of an industrial process; good potential practical application

Chemical inactivation Aflatoxins by ozonation Nixtamalization with Aflatoxins, addition of hydrogen fumonisins peroxide and sodium bicarbonate

EUROPEAN UNION [EU] 2003 EU member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, United Kingdom EU candidate member states: Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia will join the European Union per 1 May 2004; the other EU candidate member states - Bulgaria, Romania and Turkey - may join the EU later. Commodity (Sum of) Limit Leg Responsib Sampling Mycotoxin( (g/kg al le method s) ) basi authority status ref. s Analytical method status ref. Remarks

Food groundnuts, afla B1 nuts and dried afla fruit and B1B2G1G2 processed products thereof, intended for direct human consumption or as an ingredient in foodstuffs groundnuts to afla B1 be subjected afla to sorting, or B B G G 1 2 1 2 other physical treatment, 2 4 EU2 various offici EU7 offici EU7 Performanc al al e criteria for methods of analysis are given. A specific limit has been proposed for afla B1 in baby foods and processed cereal-based foods for infants and young

8 15

before human consumption or use as an nuts and dried afla B1 fruit to be subjected to sorting, or other physical treatment, before human (continued) consumption or use as an ingredient in foodstuffs afla B1B2G1G2

10

children, and in dietary foods for special medical purposes intended specifically for infants; these limits are expected to come into force in May 2004.

cereals afla B1 (including afla buckwheat, B1B2G1G2 Fagopyrum sp.) and processed products thereof intended for direct human consumption or use as an ingredient in foodstuffs cereals afla B1 (including afla buckwheat, B1B2G1G2 Fagopyrum sp.), with the exception of maize, to be subjected to sorting, or other physical treatment, before human consumption

2 4

2 4

or use as an ingredient in maize to be afla B1 subjected to afla sorting, or B1B2G1G2 other physical treatment, before human consumption or use as an ingredient in foodstuffs spices: afla B1 Capsicum afla spp. (dried B1B2G1G2 fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika); Piper spp. (fruits thereof, including white and black pepper); Myristica fragrans (nutmeg); Zingiber officinale (ginger); Curcuma longa raw cereal grains (including raw rice and buckwheat) ochratoxin A

5 10

EU3

5 10

EU4

EU8

EU8

various

EU9

EU9 Performanc e criteria for methods of analysis are given.A

all products derived from cereals (including processed cereal products and cereal grains intended for direct human consumption) dried vine fruit (currants, raisins and sultanas)

10

specific limit has been proposed for ochratoxin A in baby foods and processed cereal-based foods for infants and young children, and in dietary foods for special medical purposes intended specifically for infants; these limits are expected to come into force in May 2004. EU5 offici EU1 offici EU1 since 1 al 0 al 0 november 2003; prevention and reduction of patulin contaminati on [see EU 11]; performanc e criteria for methods of analysis are given

fruit juices patulin and fruit nectar, in particular apple juice, and fruit juice ingredients in other beverages concentrated fruit juice after reconstitution as instructed by the manufacturer spirit drinks,

50

50

50

cider and other fermented drinks derived from apples or containing apple juice solid apple products, including apple compote, apple puree intended for direct consumption apple juice and solid apple products, including apple compote and apple puree, for infants and young children and labelled and sold as intended for infants and young children other baby food (as defined in Article 1 of [EU1]) cereal products as consumed and other cereal DON 25

10

10

500

EU6

draft Commissio n Recommendation

products at retail stage flour used as raw material in food products Dairy milk (raw afla M1 milk, milk for the manufacture of milk-based products and heat-treated milk as defined by Council Directive 92/46/EEC, as last amended by Council Directive 94/71/EC) 0.05 EU2 various offici EU7 offici EU7 Performanc al al e criteria for methods of analysis are given. A specific limit has been proposed for afla M1 in infant formulae and followon formulae, including infant milk and followon milk; these limits are expected to come into force in May 2004. offici EU1 offici EU1 Maximum al 4 al 5 content EU1 relative to a 6 feedingstuff with a moisture content of 12 % 750

Feed all feed materials complete feedingstuffs for cattle, sheep and goats with the exception of: - complete feedingstuffs for dairy afla B1 20 20 EU1 various 2

animals - complete feedingstuffs for calves and lambs complete feedingstuffs for dairy animals complete feedingstuffs for calves and lambs complete feedingstuffs for pigs and poultry (except young animals) other complete feedingstuffs complementa ry feedingstuffs for cattle, sheep and goats (except complementa ry feedingstuffs for dairy animals, calves and lambs) Complementa ry feedingstuffs for pigs and poultry (except young 5

10

20

Maximum content relative to a feedingstuff with a moisture content of 12 %

10

20

20

animals) other complementa ry feedingstuffs 5

All Rye ergot *) 100000 EU1 feedingstuffs (Claviceps 0 3 containing purpurea) unground cereals

Maximum content relative to a feedingstuff with a moisture content of 12 %;*) see footnote

*) ergot means the sclerotium or dormant winter form of the fungus Claviceps purpurea. The limit refers to the weight of ergot kernels per total commodity weight, and not toxin concentration. FINLAND [FI] 2003 [EU member state] Commodit y (Sum of) Limit Lega Responsibl Sampling Analytical Remark Mycotoxin(s (g/kg l e authority method method s ) ) basis status ref status ref . .

Food see European Union [harmonized regulations] additional regulations of Finland: all spices other food products Dairy see European Union [harmonized regulations] Feed MAF [EELA] afla B1B2G1G2 10 5 FI1 MF [FC] officia FI2 officia FI3 l l MAF [EELA] & MF [FC]

see European Union [harmonized regulations] FRANCE [FR] 2003 [EU member state]

MAF [KTTK]

Commodit (Sum of) Limit Lega Responsibl Sampling Analytical Remark y Mycotoxin(s (g/kg l e authority method method s ) ) basis status ref status ref. .

Food see European Union [harmonized regulations] additional regulations of France: cereals & cereal products fumonisin B1 1000 FR1 DGCCRF nonofficia l nonFR officia 2 l FR 3 1000 g/kg target value 3000 g/kg max. limit DGCCRF

3000

zearalenone vegetable oils Dairy zearalenone

50 200

see European Union [harmonized regulations] Feed see European Union [harmonized regulations] GERMANY [DE] 2003 [EU member state]

DGCCRF & DGAL

DGCCRF & DGAL

Commodit (Sum of) Limit Lega Responsib Sampling y Mycotoxin( (g/kg l le method

Analytical method

Remarks

s)

basis authority

status ref. status ref.

Food see European Union [harmonized regulations] BMVEL & LMBG EU regulations for afla B1 and afla B1B2G1G2 are applied to other commoditi es than regulated in the EU Specific limits have been proposed for ochratoxin A, DON, Fumonisin s B1 and B2, and zearalenon e in a variety of foods. In addition specific limits have been proposed for fumonisins B1 and B2, zearalenon e and DON in raw materials intended for the production

additional regulations of Germany:

of food for infants and young children. These limits are expected to come into force in February 2004. enzymes afla and B1B2G1G2 enzyme formulatio ns used for food preparation food for afla infants and B1B2G1G3 young children Dairy see European Union [harmonized regulations] BMVEL & LMBG EU regulations for afla M1 are applied to other commoditi es than regulated in the EU 0.05 DE1 BMVEL & offici LMBG al DE 3 offici al EU 6

0.05

DE2

DE 4

additional regulations of Germany: food for afla M1 infants and young children Feed see European Union [harmonized regulations] 0.01 DE2 BMVEL & offici LMBG al DE 3 offici al DE 4